SUPPLEMENTARY INFORMATION:

The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Documentation Burden. AHRQ is conducting this review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.

The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( e.g., details of studies conducted). We are looking for studies that report on Documentation Burden. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/​products/​documentation-burden/​protocol.

This is to notify the public that the EPC Program would find the following information on Documentation Burden helpful:

A list of completed studies that your organization has sponsored for this topic. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

A list of ongoing studies that your organization has sponsored for this topic. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.

Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this topic and an index ( printed page 70662) outlining the relevant information in each submitted file.

Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effectivehealthcare.ahrq.gov/​email-updates.

The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.

Guiding Questions

Description/Overview of Measurements of Documentation Burden

(1) What metrics of documentation burden that have been developed or used (including metrics broadly—quantitative and qualitative)?

(a) For which settings, populations, and intended uses were the metrics developed?

(b) How have these metrics been applied?

(c) Is there published information available on validity of the metrics?

(d) What are the key strengths and weaknesses of different metrics that have been used?

(2) What are the different perspectives on the appropriateness of different metrics of documentation burden that have been applied/proposed ( e.g., scalability, resource intensiveness to collect, equitable across populations)?

(3) What are the perceptions of documentation burden from the perspective of people in different clinical roles ( e.g., doctor, nurse, etc.) and patients/caregivers?

Factors Influencing Documentation Burden

(4) What is the role of patients in documentation burden?

(5) What is the role of setting ( i.e., rural vs. urban, hospital, outpatient, academic institution, etc.) in documentation burden?

88 FR 70661